[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538229":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":125,"centralContacts":130,"locations":140,"responsibleParty":159,"collaborators":161,"id":165,"slug":108,"hasResults":166,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":108,"eligibilityCriteria":170,"healthyVolunteers":166,"sex":171,"minAge":108,"maxAge":108,"enrollmentInfo":172,"targetDuration":108,"studyType":175,"phases":176,"briefSummary":178,"conditions":179,"keywords":108,"overallStatus":142,"whyStopped":108,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Jonsson Comprehensive Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (177Lu-PSMA-617)","EXPERIMENTAL","Patients receive 177Lu-PSMA-617 IV on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gallium Ga 68 gozetotide IV and undergo PET\u002FCT at screening and on study, undergo SPECT\u002FCT on study, and undergo collection of blood samples throughout the trial.",[13,14,15,16,17,18,19],"Procedure: Biospecimen Collection","Procedure: Computed Tomography","Other: Gallium Ga 68 Gozetotide","Drug: Lutetium Lu 177 Vipivotide Tetraxetan","Procedure: Positron Emission Tomography","Other: Questionnaire Administration","Procedure: Single Photon Emission Computed Tomography",[21,30,44,76,91,104,109],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Biospecimen Collection","Undergo collection of blood samples",[9],[27,28,29],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Computed Tomography","Undergo PET\u002FCT and SPECT\u002FCT",[9],[35,36,37,38,39,40,41,42,43],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","CT","CT Scan","tomography",{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Gallium Ga 68 Gozetotide","Given IV",[9],[49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75],"(68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC","(68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC","(68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC","(68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC","(68Ga)Glu-urea-Lys(Ahx)-HBED-CC","68Ga-DKFZ-PSMA-11","68Ga-HBED-CC-PSMA","68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC","68Ga-PSMA","68Ga-PSMA-11","68Ga-PSMA-HBED-CC","[68Ga] Prostate-specific Membrane Antigen 11","[68Ga]GaPSMA-11","AAA 517","AAA-517","AAA517","Ga PSMA","Ga-68 labeled DKFZ-PSMA-11","Ga-68 labeled PSMA-11","GA-68 PSMA-11","Gallium Ga 68 PSMA-11","Gallium Ga 68-labeled PSMA-11","GALLIUM GA-68 GOZETOTIDE","Gallium-68 PSMA","Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC","GaPSMA","PSMA-HBED-CC GA-68",{"type":77,"name":78,"description":46,"armGroupLabels":79,"otherNames":80},"DRUG","Lutetium Lu 177 Vipivotide Tetraxetan",[9],[81,82,83,84,85,86,87,88,89,90],"177Lu-labeled PSMA-617","177Lu-PSMA-617","AAA 617","AAA-617","AAA617","Lu177-PSMA-617","Lutetium Lu 177-PSMA-617","LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN","Lutetium-177-PSMA-617","Pluvicto",{"type":22,"name":92,"description":93,"armGroupLabels":94,"otherNames":95},"Positron Emission Tomography","Undergo PET\u002FCT",[9],[96,97,98,99,100,101,102,103],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","proton magnetic resonance spectroscopic imaging","PT",{"type":6,"name":105,"description":106,"armGroupLabels":107,"otherNames":108},"Questionnaire Administration","Ancillary studies",[9],null,{"type":22,"name":110,"description":111,"armGroupLabels":112,"otherNames":113},"Single Photon Emission Computed Tomography","Undergo SPECT\u002FCT",[9],[114,115,116,117,118,119,120,121,122,123,124],"Medical Imaging, Single Photon Emission Computed Tomography","Single Photon Emission Tomography","Single-Photon Emission Computed","single-photon emission computed tomography","SPECT","SPECT imaging","SPECT SCAN","SPET","ST","tomography, emission computed, single photon","Tomography, Emission-Computed, Single-Photon",[126],{"name":127,"affiliation":128,"role":129},"Jeremie Calais, MD","UCLA \u002F Jonsson Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[131,136],{"name":132,"role":133,"phone":134,"phoneExt":108,"email":135},"Stephanie Lira","CONTACT","3102060596","StephanieLira@mednet.ucla.edu",{"name":137,"role":133,"phone":138,"phoneExt":108,"email":139},"Ethan Lam","3102067372","clam@mednet.ucla.edu",[141],{"facility":128,"status":142,"city":143,"state":144,"zip":145,"country":146,"cosmosGeoPoint":147,"geoPoint":152,"contacts":153},"RECRUITING","Los Angeles","California","90095","United States",{"type":148,"coordinates":149},"Point",[150,151],-118.24368,34.05223,{"lat":151,"lon":150},[154,156,157],{"name":137,"role":133,"phone":155,"phoneExt":108,"email":139},"310-206-7372",{"name":132,"role":133,"phone":134,"phoneExt":108,"email":135},{"name":158,"role":129,"phone":108,"phoneExt":108,"email":108},"Jeremie Calais",{"type":160,"investigatorFullName":108,"investigatorTitle":108,"investigatorAffiliation":108,"oldNameTitle":108,"oldOrganization":108},"SPONSOR",[162],{"name":163,"class":164},"Novartis Pharmaceuticals","INDUSTRY","100538229",false,"NCT06288113","Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial","Re-Treatment With 177Lu-PSMA-617 Molecular Radiotherapy for Metastatic Castration Resistant Prostate Cancer: A Prospective Phase 2 Trial (RE-LuPSMA STUDY)","Inclusion Criteria:\n\n* Patients must have mCRPC\n* Patients must have received at least one regimen of chemotherapy for mCRPC\n* Patients must have received at least one androgen receptor signaling inhibitor (ARSI)\n* Patients must have previously completed at least 4 cycles of 177Lu-PSMA-617 therapy\n* Patients must have had a favorable response to the first regimen of 177Lu-PSMA-617 therapy defined as:\n\n  * PSA decline of ≥ 50% at any time during the first regimen of 177Lu-PSMA-617 therapy AND\n  * No new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation androgen deprivation therapy \\[ADT\\] is allowed). Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed\n* Patients must have had a PSA increase after the first regimen of 177Lu-PSMA-617 therapy, confirmed by a second measurement ≥ 3 weeks apart\n* Patients must meet PSMA PET\u002FCT VISION criteria. PSMA PET\u002FCT must have been completed within 8 weeks of the planned first cycle of re-challenge 177Lu-PSMA-617 therapy and at least 6 weeks after completion of the first regimen of 177Lu-PSMA-617 therapy\n* White blood cells \\> 2,500 cells\u002FµL\n* Absolute neutrophil count \\> 1,500 cells\u002FµL\n* Hemoglobin \\> 9.0 g\u002FdL\n* Platelets \\> 100,000 cells\u002FµL\n* Patients must have the ability to understand and sign an approved informed consent form (ICF) and comply with all protocol requirements\n\nExclusion Criteria:\n\n* Patient received new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation ADT (adenosine triphosphate) is allowed). This can include apalutamide, enzalutamide, abiraterone, chemotherapy, immunotherapy, radionuclide therapy, PARP inhibitor, or any biological therapy. Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed\n* Patient received myelosuppressive therapy (including docetaxel, cabazitaxel, 223Ra, and 153Sm) or other radionuclide therapy within the last 6 weeks\n* Patient with creatinine clearance \\\u003C 50 mL\u002Fmin","MALE",{"count":173,"type":174},40,"ESTIMATED","INTERVENTIONAL",[177],"PHASE2","This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer.",[180,181],"Castration-Resistant Prostate Carcinoma","Stage IVB Prostate Cancer AJCC v8","2026-03-11",{"date":184,"type":185},"2026-03-13","ACTUAL",{"date":187,"type":185},"2024-08-01",{"date":189,"type":174},"2028-01-27",{"name":5,"class":6},1]